Can PRP Reduce Pro-Inflammatory Biomarkers Following ACL Injury
Primary Purpose
ACL - Anterior Cruciate Ligament Rupture, ACL Injury
Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Platelet Rich Plasma
Saline Placebo
Sponsored by
About this trial
This is an interventional treatment trial for ACL - Anterior Cruciate Ligament Rupture focused on measuring Platelet Rich Plasma
Eligibility Criteria
Inclusion Criteria:
- Patients have suffered an acute ACL tear (initial presentation within 7 days of injury) with or without an associated meniscus injury
- Patient must undergo ACL reconstruction surgery
Exclusion Criteria:
- Mentally impaired (e.g, Alzheimer's subjects, dementia, etc.)
- Younger than 18 years of age
- Patients who have a multiligamentous injury
- Patients with underlying inflammatory arthropathies
- Previous ACL injury and/or reconstruction
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Platelet Rich Plasma
Saline Placebo
Arm Description
Platelet Rich Plasma will be prepared using Genesis CS EmCyte PurePRP II system.
Unmarked syringe with 5 ml of saline
Outcomes
Primary Outcome Measures
synovial fluid biomarker levels
The synovial fluid samples obtained at the two time points will be analyzed for the presence of 20 biomarkers using a multiplex bead assay (Milliplex®, Millipore, Billerica MA)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03389685
Brief Title
Can PRP Reduce Pro-Inflammatory Biomarkers Following ACL Injury
Official Title
Can Platelet Rich Plasma Reduce the Level of Pro-Inflammatory Synovial Fluid Biomarkers Following an Anterior Cruciate Ligament Tear
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Suspended
Why Stopped
COVID-19, Lack of Funding
Study Start Date
September 9, 2018 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this single-center, double-blinded randomized control trial with prospective data collection is to assess the ability of platelet rich plasma (PRP) treatment to reduce the level of pro-inflammatory synovial fluid biomarkers following an acute anterior cruciate ligament (ACL) tear. The study will collect and analyze synovial fluid of patients presenting with an acute anterior cruciate ligament (ACL) tear with a second synovial fluid sampling at the time of surgery. It will compare synovial fluid biomarker levels between those receiving an intra-articular Platelet Rich Plasma (PRP) injection versus an intra-articular saline injection serving as a control. Post-operative clinical outcomes will also be assessed, including post-operative pain levels, incidence of post-operative knee stiffness and patient reported outcome scores.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL - Anterior Cruciate Ligament Rupture, ACL Injury
Keywords
Platelet Rich Plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Platelet Rich Plasma
Arm Type
Experimental
Arm Description
Platelet Rich Plasma will be prepared using Genesis CS EmCyte PurePRP II system.
Arm Title
Saline Placebo
Arm Type
Placebo Comparator
Arm Description
Unmarked syringe with 5 ml of saline
Intervention Type
Biological
Intervention Name(s)
Platelet Rich Plasma
Intervention Description
Pure PRPII®, leukocyte-poor, platelet rich plasma
Intervention Type
Other
Intervention Name(s)
Saline Placebo
Intervention Description
saline solution
Primary Outcome Measure Information:
Title
synovial fluid biomarker levels
Description
The synovial fluid samples obtained at the two time points will be analyzed for the presence of 20 biomarkers using a multiplex bead assay (Milliplex®, Millipore, Billerica MA)
Time Frame
2 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients have suffered an acute ACL tear (initial presentation within 7 days of injury) with or without an associated meniscus injury
Patient must undergo ACL reconstruction surgery
Exclusion Criteria:
Mentally impaired (e.g, Alzheimer's subjects, dementia, etc.)
Younger than 18 years of age
Patients who have a multiligamentous injury
Patients with underlying inflammatory arthropathies
Previous ACL injury and/or reconstruction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Strauss, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Can PRP Reduce Pro-Inflammatory Biomarkers Following ACL Injury
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